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Abstract

Background

During recent years laparoscopic cholecystectomy has dramatically increased, sometimes
resulting in overtreatment. Aim of this work was to retrospectively analyze all laparoscopic
cholecystectomies performed in a single center in order to find the percentage of
patients whose surgical treatment may be explained with this general trend, and to
speculate about the possible causes.

Methods

831 patients who underwent a laparoscopic cholecystectomy from 1999 to 2008 were retrospectively
analyzed.

Results

At discharge, 43.08% of patients were operated on because of at least one previous
episode of biliary colic before the one at admission; 14.08% of patients presented
with acute lithiasic cholecystitis; 14.68% were operated on because of an increase
in bilirubin level; 1.56% were operated on because of a previous episode of jaundice
with normal bilirubin at admission; 0.72% had gallbladder adenomas, 0.72% had cholangitis,
0.36% had biliodigestive fistula and one patient (0.12%) had acalculous cholecystitis.
By excluding all these patients, 21.18% were operated on without indications.

Conclusions

The broadening of indications for laparoscopic cholecystectomy is undisputed and can
be considered a consequence of new technologies that have been introduced, increased
demand from patients, and the need for practice by inexperienced surgeons. If not
prevented, this trend could continue indefinitely.

Keywords:

Background

Gallstones are a very common disease affecting up to 15% of the general population
in the US and Europe [1], with a higher prevalence in women [2]. About 50 to 70% of patients with gallstones are asymptomatic [1] and nearly 1 in 10 individuals with asymptomatic gallstones may be expected to develop
symptoms or complications that require treatment within five years [2].

Since its first introduction in the late 1980s, laparoscopic cholecystectomy has been
extensively adopted as the treatment of choice in patients with gallstones and other
less frequent benign gallbladder diseases [3] due to its undeniable advantages, such as the reduction of postoperative pain, faster
recovery, and improved cosmesis [4]. Nevertheless, the undeniable advantages related to this procedure compared to the
traditional open approach have resulted in a broadening of indications in performing
such an operation, sometimes resulting in expensive and unnecessary overtreatment
[4,5].

The aim of this work was to retrospectively analyze all patients who underwent a laparoscopic
cholecystectomy in our department in order to find the percentage of patients whose
surgical treatment may be explained with the general trend of increase in laparoscopy
utilization, and to speculate about the possible causes.

Methods

All patients who underwent a laparoscopic cholecystectomy at the Department of Surgical
Sciences, Organ Transplantation and Advanced Technologies of University of Catania
- Cannizzaro Hospital from 1999 to 2008 were retrospectively analyzed after approval
of hospital ethics committee. Data were collected from medical records and patients
were analyzed depending on the symptoms at admission and diagnosis at discharge in
order to find the percentage of patients admitted and subsequently operated on with
no indication. Patients operated with open technique and those who experienced a conversion
to laparotomy were not considered for the present study.

Patient preoperative assessment was performed according the standard of care in our
practice by routine laboratory tests and ultrasound (US). Computed tomography (CT)
scan was performed only in cases of unclear diagnosis.

Patients who were diagnosed for gallstones at FAST and subsequently operated on at
the resolution of the main cause of admission were also included in the present study.

Diagnosis of acute cholecystitis was based on the presence of right upper quadrant
pain with or without fever and with evidence of raised WBC count, ultrasonographic
evidence of gallstones, pericholecystic fluid collection, gall bladder wall thickness
and thick wall contracted gall bladder.

According to the evidences in literature [6-11], conditions that were considered correct indications for surgery were the following:
acute cholecystitis (including complicated form such as gallbladder perforation and
gangrene), acute biliary pancreatitis, gallbladder adenomas, cholangitis with evidence
of gallstones, biliodigestive fistula and Mirizzi syndrome, lithiasis of the biliary
ducts with or without jaundice, recurrent episodes of biliary colic or recurrent jaundice
and the rare Bouveret syndrome. Conversely, medical records of patients who were admitted
only because of the general diagnosis of abdominal pain with gallstones, or patients
without symptoms in which diagnosis was performed incidentally during FAST exam for
trauma were further analyzed in order to find the percentage of patients operated
on without indication.

Patients with gallstones and vague abdominal pain with atypical localization or characteristics,
who underwent an operation for gallbladder stones without previous episodes of pain,
jaundice, increase in WBC count or bilirubin were considered as operated on without
indication. These patients were subsequently contacted by telephone and an oral questionnaire
was administered in order to assess the percentage of those who experienced early
(within 30 days) or delayed recurrence of symptoms, as well as those who had no improvement
in symptoms despite the operation.

Local ethics committee who gave approval for the study

Cannizzaro Hospital Ethics Commettee.

Results

From 1999 to 2008, 987 patients underwent a cholecystectomy. Among these, 105 patients
(10.64%) underwent a primary open operation and 51 patients (5.17%) experienced a
conversion to laparotomy after a laparoscopic attempt, so these 156 patients were
excluded from the study. Among the remaining 831 patients, 495 (59.57%) were female.
The main characteristics of these patients are shown in Table 1. Twenty-nine (3.49%) patients were diabetic and 20 (2.41%) were cirrhotic. The median
age (25-75th percentile) was 57 years (43-68).

The operative trend during the nine-year period with regard to the approaches performed
is shown in Figure 1 and Table 2, which compare the number of laparoscopic cholecystectomies performed with open cholecystectomies
and conversions to laparotomy. The study started when the laparoscopic cholecystectomy
had already become the standard of care in our practice, replacing the open approach
in most uncomplicated patients. At the beginning of 1999, the percentage of open cholecystectomy
was higher, as a residual of the previous trend.

Figure 1.The operative trend during the nine-year period of study, with regard to the approaches
performed. The study started when the laparoscopic cholecystectomy had already become the standard
of care at our Department, replacing the open approach in most uncomplicated patients.
A residual of the previous trend is evident at the beginning of the 1999, when the
percentage of open cholecystectomy was higher. VLS: laparoscopic cholecistectomies;
OPEN: open cholecystectomies; CONV: conversions.

The main causes of admission followed by surgery were: abdominal pain, jaundice, acute
pancreatitis and abdominal trauma.

At discharge, all patients were diagnosed as follows (Figure 2): 358 patients (43.08%) were operated on because of at least one previous episode
of biliary colic before the one at admission and among these, 314 (37.79%) had simple
gallstones at pathological exam, 36 (4.33%) had chronic lithiasic cholecystitis and
8 (0.96%) had gallbladder carcinoma. One hundred seventeen patients (14.08%) presented
with acute lithiasic cholecystitis (defined by the presence of right upper quadrant
pain with fever, raised WBC count, ultrasonographic evidence of gallstones with associated
signs of inflammation). One hundred twenty-two patients (14.68%) were operated on
because of an increase in bilirubin level (51 of these with radiological detection
of choledocholithiasis and 26 with associated increase of WBC count). Thirteen patients
(1.56%) were operated on because of a previous episode of jaundice with normal bilirubin
at admission. Six patients (0.72%) had gallbladder adenomas. Six patients (0.72%)
had cholangitis. Three patients (0.36%) had biliodigestive fistula and one patient
(0.12%) had acalculous cholecystitis. No Mirizzi or Bouveret syndrome was detected.

Figure 2.Criteria of inclusion and indications to surgery with related diagnosis at discharge.

By excluding all these patients, 176 patients (21.18% including 78 patients admitted
only for gallstones presence diagnosed incidentally at FAST) were operated on without
indication for vague symptoms not related to gallstones or for request of the patients.

The main characteristics of this subpopulation of 176 patients are reported in Table 3. Most of these patients (64.77%) were female, with a median age (25-75th percentile) of 54 (44-65) years.

At follow-up, 150 of 176 patients (85,23%) were contacted by telephone (19 were unavailable
and 7 died for causes unrelated to gallbladder disease) and an oral questionnaire
was administered with the following results: 6 patients (4%) experienced early recurrence
of pain within 30 days after the cholecystectomy; 34 patients (22,66%) experienced
late recurrence of pain (30 days after operation); 107 patients (71,33%) referred
no improvement in symptoms after operation, with persistence of the same preoperative
vague pain whose source required further exams (e.g. gastroscopy, computed tomography,
magnetic resonance imaging) to be identified. Only 3 patients (2%) referred complete
disappearance of pain after operation. In conclusion, for 147 patients (98%) included
in follow-up, cholecystectomy determined no early or late improvement in symptoms,
confirming that these symptoms were not related to gallstones and the operation should
have been avoided.

Discussion

Immediately following the introduction of laparoscopic cholecystectomy, many authors
have detected a dramatic increase in the amount of cholecystectomies performed in
general hospitals. From 1990 to 1993, for instance, this increase has been approximately
30% in New York [4]. Others report the same remarkable trend during the years 1990-2001, with a peak
between 1994-1998 and a subsequent stabilization through 2001 [5]. Many reasons have been proposed to explain this growth trend. Initially, it was
speculated that the increase was due to a high number of patients who put off having
the operation for fear of the consequences of the laparotomic approach, but then decided
to be operated on given the favorable outcome related to laparoscopy [4]. However, if true, the increase of laparoscopic cholecystectomies should have been
temporary and would have been extinguished in a few years concurrent with the decrease
in the procrastinating patients [4]. Conversely, the increase in laparoscopic cholecystectomies has been maintained.
In a very extensive review of cholecystectomies performed over time in the state of
Maryland, involving more than 54 institutions, between 1985 and 1992, the annual cholecystectomy
rate had risen from 1.69 per 1000 to 2.17 per 1000, representing a 28-percent increase.
This increase was considered as related to the introduction of laparoscopic technique,
in which younger patients, less likely to have acute cholecystitis and/or have common
bile duct stones, had acquiesced to have surgery. The gained benefit was a reduction
in the overall mortality of this operation from 0.84 percent in 1989 to 0.56 percent
in 1992 (a 33% reduction), at the expense of an increased rate, for more benign and
lesser symptomatic cases, including possible doubtful indications [12].

General indications and contraindication for performing laparoscopic cholecystectomy
are well established [6]. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) guidelines
for the clinical application of laparoscopic biliary tract surgery [7] indicate that conditions requiring cholecystectomy include but are not limited to
cholelithiasis (when symptomatic), choledocholithiasis, biliary dyskinesia, porcelain
gallbladder, acute cholecystitis and pancreatitis related to common bile duct stones.
Asymptomatic gallstones are not included among the indications for laparoscopic cholecystectomy
[7], although, according to Murshid et al, the distance to facility, long waiting lists
in small centers, and even the unavailability of an experienced surgeon may represent
an indication to perform the laparoscopic cholecystectomy in absence of symptoms [13]. Other indications for surgery in patients with asymptomatic gallstones such as advanced
age, diabetes, gallbladder adenomyomatosis and risk of gallbladder cancer are still
the subject of debate [14-17]. Regardless of these specific or rare conditions, we can conclude that there is general
agreement that patients with asymptomatic gallstones do not require operation.

To the best of our knowledge, this is the first work which retrospectively analyzes
all patients who underwent a laparoscopic cholecystectomy in order to find the percentage
of patients submitted to this procedure with no indication or doubtful indications.
It is remarkable that 78 patients (that is 9.38% of the cohort) were admitted and
subsequently operated on only due to presence of gallstones diagnosed incidentally
at FAST, without history associated symptoms. By collecting data from the diagnoses
at discharge, the proportion of patients operated on with no indication resulted in
an even greater percentage (176 patients who represent 21.18% of the cohort). Almost
98% of this group of patients with indefinite symptoms presented vague symptoms again
after the cholecystectomy, demonstrating that the symptoms that led to cholecystectomy
were not related to the presence of the gallbladder stone and determining the need
of further exams to identify their source.

Speculating about the possible reasons for these data, it is important to note that
gallstones are frequently considered the cause of a multitude of abdominal symptoms
and, after detection, the patient is usually operated on without further investigations
that, conversely, are performed only when symptoms relapse after surgery. Second,
it is possible that the increased patient demand due to benefits of laparoscopy and
fear of stones complications plays a determining role. Finally, the need for practice
by inexperienced surgeons should be considered.

It has been proven that the risk of major bile duct injuries is still greater with
laparoscopy rather than with the open approach [9,18]. By collecting data among patients operated on with doubtful of no indications, we
did not detected any complications directly related to the procedure performed at
our institution, but it is possible to suppose that an irresponsible increase in useless
laparoscopic procedures could also result in an increase in bile duct injuries or
other complications.

Finally, one question should be addressed: given the importance of surgical skills
set in such a different laparoscopic procedure, how critical is the surgeon’s training
in determining an increase in useless cholecystectomies? Could the constant introduction
of different devices and approaches be responsible for an increase in operations performed
on “easy” patients who would not otherwise need surgery?

Conclusion

The increase in doubtful indications is recognized, and it can be considered a consequence
of the new technologies introduced, an increasing in minimal access experience and
demand of patients for laparoscopic surgery, with no associated modifications of the
standard indications. If not prevented, this trend could continue indefinitely.

Competing interests

All the authors declare that they have no competing interests.

Authors’ contributions

Contributions to conception and design: IDiC, AT; Acquisition of data, EP, MM; Analysis
and interpretation of data: AT, EP; Have been involved in drafting the manuscript:
AT, EP; Revising it critically for important intellectual content: IDiC, MG; Have
given final approval of the version to be published: IDiC. All authors read and approved
the final manuscript.